Anticoagulation Therapy in the Very Old

Completed

Brief Summary: This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.

Detailed Description: This is a prospective registry study with data being collected continuously for 24 months.

Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.

Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.

Recruitment & Eligibility

Inclusion Criteria

70 years of age or older
electrocardiographically confirmed atrial fibrillation
anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
Subject or legally authorized representative must be willing to provide informed consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Aged 90 and older	Warfarin	Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Aged 70-79	Warfarin	Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Aged 80-89	Warfarin	Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing a Major Bleeding Event	24 months	defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells
Number of Patients Experiencing Stroke	24 months	Every 6 months the medical record was reviewed for evidence of stroke of any cause.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Experiencing a Traumatic Subdural Hemorrhage	24 months	Number of subjects who experienced a traumatic subdural hemorrhage in each age group
Number of Patients Experiencing Death Related to Anticoagulation	24 months	All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy.
Number of Patients Experiencing Cardiovascular Death	24 months	Every 6 months the medical record was reviewed. All deaths were researched for cause and noted if the cause was related to the cardiovascular system.
Number of Hospitalizations Patients Experienced	24 months	Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.
Mean Time in Therapeutic Range at End of Study Participation	up to 24 months	International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.
Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage	24 months	Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group